Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
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ClinicalTrials.gov Identifier: NCT01760616 |
Recruitment Status :
Terminated
(difficult to recruit patients)
First Posted : January 4, 2013
Last Update Posted : March 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Hepatic Carcinoma | Drug: Huaier Granule | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 790 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy |
Actual Study Start Date : | November 7, 2011 |
Actual Primary Completion Date : | August 15, 2015 |
Actual Study Completion Date : | June 30, 2017 |
Arm | Intervention/treatment |
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Experimental: Test group
Test group: Adjuvant therapy + Huaier Granule group.Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment
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Drug: Huaier Granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd.. |
No Intervention: Control group: adjuvant therapy
Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment.
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- Time to significant progression after surgery and postoperative survival period. [ Time Frame: 3 years ]Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.
- ECOG and QLQ-C30 scores [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale.
- Iconography assessment [ Time Frame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year.
- Alpha-fetoprotein quantitation and related biochemical indicators [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: ≥ 18 and ≤ 75 years, both male and female;
- Non-radical hepatectomy has been performed for hepatocellular carcinoma;
- The hepatocellular carcinoma has been confirmed by pathological examination;
- The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin ≤2 ULN, serum creatinine <1.5 ULN;
- Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, neutrophil count> 1.5×109/L;
- The expected survival time ≥12 weeks;
- The subjects volunteer to sign the informed consent.
Exclusion Criteria:
- Non-hepatocellular carcinoma patients;
- Those who received radical hepatectomy;
- Those with hepatic decompensation;
- Pregnant or lactating women;
- Those with HIV infection or AIDS-associated diseases;
- Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
- Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
- Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- Conditions that are considered not suitable for this study investigators.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760616
China, Hubei | |
Tongji Hospital Affiliated to Tongji Medical College, Huazhong | |
Wuhan, Hubei, China |
Principal Investigator: | Xiaoping Chen, Professor | Huazhong University of Science and Technology |
Responsible Party: | Qidong Gaitianli Medicines Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01760616 |
Other Study ID Numbers: |
HE-201102 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | March 6, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Huaier Granule; After non-radical hepatectomy; Prevention of Disease Progression of Hepatocarcinoma; Safety. |
Carcinoma, Hepatocellular Disease Progression Disease Attributes Pathologic Processes Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |